Pancreatic CancerPhase 2NCT07542002
Liposomal Irinotecan, 5-fluorouracil/Calcium Folinate, Oxaliplatin, and Adebrelimab in Combination With Radiotherapy for Resectable or Borderline Resectable Pancreatic Cancer With Risk Factors：A Prospective Exploratory Study
A Phase 2 study testing Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adadelimab. in people with Pancreatic Cancer, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
Trial summary
Pancreatic cancer is a highly malignant digestive system tumor with a very poor prognosis. In recent years, both the incidence and mortality rates of pancreatic cancer have shown a marked upward trend worldwide. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adadelimab.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2025to 31 May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet the following criteria to be eligible for enrollment in this study:
- Age 18 to 75 years, regardless of gender;
- Histologically or cytologically confirmed pancreatic cancer (arising from the pancreatic ductal epithelium), as assessed by a multidisciplinary team (MDT), with clinical records indicating resectable or borderline resectable pancreatic cancer with high-risk factors. (According to the 2022 edition of the CSCO guidelines, borderline resectable pancreatic cancer is defined as: ① Tumor contact with the portal vein-superior mesenteric vein > 180°, or contact ≤180° combined with irregular venous contour or venous thrombosis, but with the possibility of complete resection and safe reconstruction; tumor contact with the inferior vena cava; ② (For pancreatic head/uncinate process tumors) Tumor contact with the common hepatic artery, but without involvement of the celiac artery or the origin of the left or right hepatic arteries, with the possibility of complete resection and safe reconstruction; tumor contact with the superior mesenteric artery ≤180°; tumor contact with variant arteries (e.g., accessory right hepatic artery, replaced right hepatic artery, replaced common hepatic artery, etc.). (For pancreatic body/tail tumors) Tumor contact with the superior mesenteric artery ≤180°; tumor contact with the celiac artery ≤180°.) (According to the 2022 edition of the CSCO guidelines, high-risk factors are defined as "very high CA19-9, large primary tumor, massive regional lymph node metastasis, significant weight loss, and severe pain." In this study, high-risk factors are defined as "CA199 > 200 U/mL, maximum tumor diameter > 2 cm, N1 or higher.")
- Presence of at least one measurable lesion as a target lesion (according to RECIST v1.1 criteria);
- No prior anti-tumor treatment (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) or investigational drug therapy;
- ECOG performance status: 0-1;
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- Life expectancy of ≥ 3 months;
- Adequate function of major organs, defined as meeting the following criteria (without transfusion of blood products or administration of hematopoietic growth factors within 14 days prior to randomization):
- Absolute neutrophil count ≥ 1.5 × 10⁹/L; platelets ≥ 80 × 10⁹/L; hemoglobin ≥ 9 g/dL; serum albumin ≥ 3 g/dL; (2) Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (biliary drainage is permitted for biliary obstruction); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (for patients with liver metastasis, up to ≤ 5 × ULN is allowed); (3) Serum creatinine ≤ 1.5 × ULN, and creatinine clearance ≥ 60 mL/min; (4) International Normalized Ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (patients on stable doses of anticoagulation therapy, such as low molecular weight heparin or warfarin, with INR within the therapeutic range of the anticoagulant, are eligible for screening); (5) Electrocardiogram: QTcF ≤ 450 ms (male), ≤ 470 ms (female); (6) Echocardiogram: Left ventricular ejection fraction (LVEF) ≥ 50%; 8. Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to randomization and agree to use an appropriate method of contraception during the study and for 6 months after the end of treatment. For men, they should be surgically sterile or agree to use an appropriate method of contraception during the study and for 3 months after the end of treatment; 9. The subject voluntarily agrees to participate in this study and provides written informed consent.
Who cannot join
- Patients with any of the following criteria are ineligible for enrollment in this study:
- Pancreatic cancer originating from non-ductal epithelium of the pancreas, including pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary neoplasms;
- Patients with known central nervous system metastasis;
- Severe gastrointestinal dysfunction (e.g., bleeding, obstruction; inflammation greater than Grade 2; diarrhea greater than Grade 1);
- Presence of third-space effusions (other than ascites) that cannot reach a stable state within 2 weeks prior to randomization (e.g., large pleural effusion that requires intervention after removal of drainage);
- Clinically symptomatic ascites requiring paracentesis or drainage, or patients who have undergone ascites drainage within the past 3 months (exceptions include those with minimal ascites detectable only on imaging and controllable without clinical symptoms);
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- Known interstitial lung disease, excluding interstitial changes detected only on imaging;
- Known peripheral neuropathy (CTCAE ≥ Grade 3);
- Known deficiency or low activity of dihydropyrimidine dehydrogenase;
- Severe infection within 4 weeks prior to enrollment (CTCAE > Grade 2), such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; presence of signs and symptoms of infection within 2 weeks prior to randomization that require intravenous antibiotic therapy (excluding prophylactic use of antibiotics);
- Receipt of any of the following treatments:
- Use of strong inhibitors/inducers of CYP3A4, CYP2C8, or strong inhibitors of UGT1A1 within 2 weeks prior to enrollment;
- Radiotherapy within 2 weeks prior to enrollment;
- Major surgery (e.g., thoracotomy, laparotomy) within 4 weeks prior to enrollment;
- Other investigational drug therapy within 4 weeks prior to enrollment, unless it was an observational (non-interventional) clinical study or follow-up of an interventional clinical study;
- Abnormal coagulation function, tendency to bleed, or ongoing thrombolytic or anticoagulant therapy. Low-dose aspirin (≤100 mg/day) and low molecular weight heparin (e.g., enoxaparin 40 mg/day or equivalent doses of other low molecular weight heparins) for prophylactic use are permitted;
- Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA Class 2 or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past 6 months; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- History of malignancies other than pancreatic cancer within 5 years prior to enrollment, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin;
- Known hypersensitivity to irinotecan liposome, other liposomal products, oxaliplatin, 5-FU, leucovorin calcium, adadelimab, or any component of the above products;
- Known acquired immunodeficiency syndrome (AIDS) or HIV-positive status, active syphilis infection;
- History of definite neurological or psychiatric disorders, including epilepsy or dementia;
- As judged by the investigator, the subject has other factors that may lead to forced discontinuation of the study, such as non-compliance with the protocol, concomitant treatment required for other severe diseases (including psychiatric diseases), clinically significant laboratory abnormalities, family or social factors that may affect the subject's safety or the collection of trial data, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo
Ningbo Medical Center Lihuili Hospital, 0574-87018834, lihuiliethics@163.com
About this study
Pancreatic cancer is a highly malignant digestive system tumor with a very poor prognosis. In recent years, both the incidence and mortality rates of pancreatic cancer have shown a marked upward trend worldwide. Global cancer statistics from 2020 indicate that approximately 495,000 new cases of pancreatic cancer are diagnosed annually, with about 466,000 deaths attributed to this disease each year. Based on the anatomical relationship between the tumor and blood vessels, pancreatic cancer is classified into three types: resectable, borderline resectable, and unresectable. The onset of pancreatic cancer is often insidious, with approximately 80% of patients presenting with advanced disease at the time of initial diagnosis, thereby losing the opportunity for radical surgical resection. Only 15-20% of patients are eligible for radical surgery at the time of initial diagnosis. However, even after surgical resection, many patients still experience early recurrence, leading to a very poor prognosis. This highlights the significant limitations of relying solely on surgery for disease control.
Currently, there is no standard neoadjuvant treatment protocol for pancreatic cancer. Recent neoadjuvant clinical trials have primarily referenced chemotherapy regimens used for advanced pancreatic cancer, which may include chemotherapy and/or radiotherapy. Recommended chemotherapy regimens include the FOLFIRINOX regimen, gemcitabine plus nab-paclitaxel, gemcitabine plus cisplatin (for BRCA1/2 mutations), and gemcitabine plus S-1. At the 2023 ASCO Annual Meeting, updated data from the NAPOLI-3 study showed that the NALIRIFOX regimen (irinotecan liposome, oxaliplatin, 5-fluorouracil, and leucovorin) achieved overall survival (OS) endpoints in first-line treatment of metastatic pancreatic cancer patients compared to the AG regimen, with clinical significance. Based on this study, the NCCN guidelines have included the NALIRIFOX regimen as a recommended first-line treatment for advanced pancreatic cancer. Given the therapeutic and safety advantages of irinotecan liposome over irinotecan in pancreatic cancer, this study aims to further explore the efficacy and safety of irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab combined with radiotherapy for resectable or borderline resectable pancreatic cancer with high-risk factors. The goal is to identify a more effective treatment option for patients with borderline resectable pancreatic cancer (BRPC) and resectable pancreatic cancer (RPC), thereby improving survival outcomes.
This study is a prospective, single-arm, exploratory trial designed to evaluate the efficacy and safety of irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab combined with radiotherapy for resectable or borderline resectable pancreatic cancer with high-risk factors, with a planned enrollment of 37 patients. After screening and meeting the inclusion and exclusion criteria, eligible patients will provide informed consent and undergo neoadjuvant treatment with irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab (with a 2-week cycle) for a total of four cycles of preoperative chemotherapy combined with immunotherapy, along with five sessions of short-course radiotherapy.
- Conditions
- Pancreatic Cancer
- Being tested
- Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adadelimab.
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adadelimab.Drug
Neoadjuvant Chemotherapy and Immunotherapy Oxaliplatin for injection: A dose of 85 mg/m² administered via intravenous infusion over 2 hours, or according to the clinical practice of the research center.
Irinotecan liposome: A dose of 56.5 mg/m² administered via intravenous infusion over 90 minutes (±30 minutes).
Leucovorin calcium: A dose of 200 mg/m² infused intravenously over 30 minutes, or according to the clinical practice of the research center.
5-Fluorouracil: A dose of 2000 mg/m² administered via intravenous infusion over 46-48 hours, or according to the clinical practice of the research center.
Adadelimab: 1200 mg administered via intravenous infusion over 30-60 minutes on Day 1, every 4 weeks.
Concurrent Short-Course Radiotherapy:
Stereotactic body radiation therapy (SBRT) is used to irradiate only the primary tumor and metastatic lymph nodes, without prophylactic irradiation of adjacent regional lymph nodes. The total dose is 25 Gy, delivered in 5 fractions of 5 Gy each.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adade | Experimental | Not described Receives: Drug: Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adadelimab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The R0 resection rate
It is defined as the proportion of subjects evaluated as having undergone R0 resection after the operation.
Measured: Through study completion, an average of 2 year.
Secondary outcomes (5)
Overall survival
It is defined as the time from randomization (or start of treatment) until death from any cause.
Measured: Through study completion，an average of 2 year
Event-Free Survival
It is defined as the period from the date of randomization of the subjects to the occurrence of tumor progression that makes surgery impossible, postoperative recurrence/metastasis, or death, whichever occurs first.
Measured: Through study completion, an average of 1 year
Objective Response Rate
It is defined as the proportion of patients whose tumor volume reduction reaches a predetermined threshold (usually complete response + partial response) and maintains the minimum time requirement.
Measured: Through study completion, an average of 2 year
Pathological Complete Response
It is defined as no residual active tumor cells being found in the surgically resected tumor tissue after neoadjuvant therapy.
Measured: Through study completion, an average of 2 year
Adverse events and A serious adverse event
Adverse events (AE) refer to adverse medical events that occur in patients after they receive a certain drug, but they do not necessarily have a causal relationship with the treatment. AE can be any adverse and unwanted symptoms, signs, abnormal laboratory tests or diseases, etc.
A serious adverse event (SAE) refers to an adverse event that occurs during the research process and meets one or more of the following criteria:
Incidents resulting in death; Life-threatening (The term "life-threatening" means that the patient is at risk of death at the time of the event/reaction; it does not mean that death may occur only when the event/reaction deteriorates further); Hospitalization is required or the current hospital stay is extended; Events that result in permanent or severe disability/loss of function; Congenital abnormalities or birth defects; Other significant medical events refer to those events/reactions that, although not immediately life-threatening, cause death or hospitali
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start25 Mar 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542002
- Sponsor's protocol ID
- KY2024PJ275
- Status last verified
- Jul 2025
- First submitted
- 12 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Irinotecan, 5-fluorouracil/Calcium Folinate, Oxaliplatin, and Adebrelimab in Combination With Radiotherapy for Resectable or Borderline Resectable Pancreatic Cancer With Risk Factors：A Prospective Exploratory Study
- ClinicalTrials.gov ID
- NCT07542002
- Acronym / sponsor ID
- KY2024PJ275
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic cancer is a highly malignant digestive system tumor with a very poor prognosis. In recent years, both the incidence and mortality rates of pancreatic cancer have shown a marked upward trend worldwide. Global cancer statistics from 2020 indicate that approximately 495,000 new cases of pancreatic cancer are diagnosed annually, with about 466,000 deaths attributed to this disease each year. Based on the anatomical relationship between the tumor and blood vessels, pancreatic cancer is classified into three types: resectable, borderline resectable, and unresectable. The onset of pancreatic cancer is often insidious, with approximately 80% of patients presenting with advanced disease at the time of initial diagnosis, thereby losing the opportunity for radical surgical resection. Only 15-20% of patients are eligible for radical surgery at the time of initial diagnosis. However, even after surgical resection, many patients still experience early recurrence, leading to a very poor prognosis. This highlights the significant limitations of relying solely on surgery for disease control.
Currently, there is no standard neoadjuvant treatment protocol for pancreatic cancer. Recent neoadjuvant clinical trials have primarily referenced chemotherapy regimens used for advanced pancreatic cancer, which may include chemotherapy and/or radiotherapy. Recommended chemotherapy regimens include the FOLFIRINOX regimen, gemcitabine plus nab-paclitaxel, gemcitabine plus cisplatin (for BRCA1/2 mutations), and gemcitabine plus S-1. At the 2023 ASCO Annual Meeting, updated data from the NAPOLI-3 study showed that the NALIRIFOX regimen (irinotecan liposome, oxaliplatin, 5-fluorouracil, and leucovorin) achieved overall survival (OS) endpoints in first-line treatment of metastatic pancreatic cancer patients compared to the AG regimen, with clinical significance. Based on this study, the NCCN guidelines have included the NALIRIFOX regimen as a recommended first-line treatment for advanced pancreatic cancer. Given the therapeutic and safety advantages of irinotecan liposome over irinotecan in pancreatic cancer, this study aims to further explore the efficacy and safety of irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab combined with radiotherapy for resectable or borderline resectable pancreatic cancer with high-risk factors. The goal is to identify a more effective treatment option for patients with borderline resectable pancreatic cancer (BRPC) and resectable pancreatic cancer (RPC), thereby improving survival outcomes.
This study is a prospective, single-arm, exploratory trial designed to evaluate the efficacy and safety of irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab combined with radiotherapy for resectable or borderline resectable pancreatic cancer with high-risk factors, with a planned enrollment of 37 patients. After screening and meeting the inclusion and exclusion criteria, eligible patients will provide informed consent and undergo neoadjuvant treatment with irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab (with a 2-week cycle) for a total of four cycles of preoperative chemotherapy combined with immunotherapy, along with five sessions of short-course radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adade | Experimental | Drug: Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adadelimab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 75 years, regardless of gender;
- Histologically or cytologically confirmed pancreatic cancer (arising from the pancreatic ductal epithelium), as assessed by a multidisciplinary team (MDT), with clinical records indicating resectable or borderline resectable pancreatic cancer with high-risk factors. (According to the 2022 edition of the CSCO guidelines, borderline resectable pancreatic cancer is defined as: ① Tumor contact with the portal vein-superior mesenteric vein > 180°, or contact ≤180° combined with irregular venous contour or venous thrombosis, but with the possibility of complete resection and safe reconstruction; tumor contact with the inferior vena cava; ② (For pancreatic head/uncinate process tumors) Tumor contact with the common hepatic artery, but without involvement of the celiac artery or the origin of the left or right hepatic arteries, with the possibility of complete resection and safe reconstruction; tumor contact with the superior mesenteric artery ≤180°; tumor contact with variant arteries (e.g., accessory right hepatic artery, replaced right hepatic artery, replaced common hepatic artery, etc.). (For pancreatic body/tail tumors) Tumor contact with the superior mesenteric artery ≤180°; tumor contact with the celiac artery ≤180°.) (According to the 2022 edition of the CSCO guidelines, high-risk factors are defined as "very high CA19-9, large primary tumor, massive regional lymph node metastasis, significant weight loss, and severe pain." In this study, high-risk factors are defined as "CA199 > 200 U/mL, maximum tumor diameter > 2 cm, N1 or higher.")
- Presence of at least one measurable lesion as a target lesion (according to RECIST v1.1 criteria);
- No prior anti-tumor treatment (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) or investigational drug therapy;
- ECOG performance status: 0-1;
Key exclusion criteria (22 listed)
- Pancreatic cancer originating from non-ductal epithelium of the pancreas, including pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary neoplasms;
- Patients with known central nervous system metastasis;
- Severe gastrointestinal dysfunction (e.g., bleeding, obstruction; inflammation greater than Grade 2; diarrhea greater than Grade 1);
- Presence of third-space effusions (other than ascites) that cannot reach a stable state within 2 weeks prior to randomization (e.g., large pleural effusion that requires intervention after removal of drainage);
- Clinically symptomatic ascites requiring paracentesis or drainage, or patients who have undergone ascites drainage within the past 3 months (exceptions include those with minimal ascites detectable only on imaging and controllable without clinical symptoms);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adadelimab.Neoadjuvant Chemotherapy and Immunotherapy Oxaliplatin for injection: A dose of 85 mg/m² administered via intravenous infusion over 2 hours, or according to the clinical practice of the research center. Irinotecan liposome: A dose of 56.5 mg/m² administered via intravenous infusion over 90 minutes (±30 minutes). Leucovorin calcium: A dose of 200 mg/m² infused intravenously over 30 minutes, or according to the clinical practice of the research center. 5-Fluorouracil: A dose of 2000 mg/m² administered via intravenous infusion over 46-48 hours, or according to the clinical practice of the research center. Adadelimab: 1200 mg administered via intravenous infusion over 30-60 minutes on Day 1, every 4 weeks. Concurrent Short-Course Radiotherapy: Stereotactic body radiation therapy (SBRT) is used to irradiate only the primary tumor and metastatic lymph nodes, without prophylactic irradiation of adjacent regional lymph nodes. The total dose is 25 Gy, delivered in 5 fractions of 5 Gy each. | Drug | Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adade |
Primary outcome
The R0 resection rate
Time frame: Through study completion, an average of 2 year.
It is defined as the proportion of subjects evaluated as having undergone R0 resection after the operation.
5 secondary outcomes
Overall survival
Time frame: Through study completion，an average of 2 year
Event-Free Survival
Time frame: Through study completion, an average of 1 year
Objective Response Rate
Time frame: Through study completion, an average of 2 year
Pathological Complete Response
Time frame: Through study completion, an average of 2 year
Adverse events and A serious adverse event
Time frame: Through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adadelimab. in people with Pancreatic Cancer, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SHENGDONG WU (008613567886669, 13567886669@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The R0 resection rate (time frame: Through study completion, an average of 2 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.